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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Hodgkin's Disease

Intervention: Vinblastine sulfate (Drug); Dacarbazine (Drug); Filgrastim (Drug); Bleomycin sulfate (Drug); Doxorubicin hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Levine A, Study Chair

Summary

Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.

Clinical Details

Official title: Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Detailed description: Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response. Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Concurrent Medication: Required:

- PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.

Recommended:

- Antiemetic therapy within 30 minutes of chemotherapy.

Allowed:

- Antiretroviral medication after two cycles of chemotherapy, provided the patient has

not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy.

- Acetaminophen and/or nonsteroidal anti-inflammatory agents.

- Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone.

- Maintenance therapy for chronic opportunistic infection.

Concurrent Treatment: Allowed:

- Cranial irradiation (2400 rads) for patients with CNS involvement.

Patients must have:

- Documented HIV infection or diagnosis of AIDS.

- Hodgkin's disease.

- Consent of parent or guardian and have care directly supervised by a pediatric

oncologist if under 18 years of age. Prior Medication: Allowed:

- Maintenance therapy for opportunistic infections.

Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:

- Second primary cancer other than Kaposi's sarcoma that does not require systemic

therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix.

- Acute, active bacterial or opportunistic infection requiring ongoing therapy if such

therapy has been initiated within the past 2 weeks.

- Known hypersensitivity (e. g., anaphylactoid reaction, bronchospasm) to E.

coli-derived proteins. Prior Medication: Excluded:

- Prior chemotherapy for Hodgkin's disease.

- Antiretroviral therapy within 2 weeks prior to study entry.

Prior Treatment: Excluded:

- Prior radiotherapy for Hodgkin's disease.

Locations and Contacts

Alabama Therapeutics CRS, Birmingham, Alabama 35294, United States

USC CRS, Los Angeles, California 900331079, United States

Northwestern University CRS, Chicago, Illinois 60611, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana 462025250, United States

St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri 63112, United States

Washington U CRS, St. Louis, Missouri, United States

SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States

The Ohio State Univ. AIDS CRS, Columbus, Ohio 432101228, United States

Additional Information

Related publications:

Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50.

Levine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194


Last updated: May 22, 2012

Page last updated: August 23, 2015

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